Experience with sorafenib and adverse event management.

Sorafenib was the first multikinase inhibitor to be approved for use in renal cell cancer (RCC) in the US (2005) and in Europe (2006). In the Treatment Approaches in Renal Cell Cancer Global Evaluation Trial (TARGET), sorafenib showed a significant progression-free survival advantage over placebo in patients with advanced RCC. Incidence rates of adverse events were significantly higher with sorafenib than with placebo. Management of adverse events is an essential component of care to prevent negative impact on patient quality of life and dose modification of sorafenib therapy. This report, based on an expert panel discussion held in February 2009, presents recommendations for the management of skin rash, hand-foot skin reaction, diarrhea, and hypertension, and strategies to help lessen the frequency and severity of these events. In addition, general recommendations for dose modifications are discussed. The goal of these management recommendations is to optimize sorafenib therapy for advanced RCC.